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NCT Number: NCT03926013

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
  • Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.
  • Evidence of disease progression on prior therapy that requires a new line of treatment
  • Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk

Exclusion criteria

  • Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
  • Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
  • Solid organ or bone marrow transplantation
  • Seizure or known condition that may predispose to seizure or intracranial masses
  • Other active malignancy requiring systemic treatment <=12 months prior to enrollment

Treatment and study plan

JNJ-63898081

Drug

JNJ-63898081 will be administered.

Primary outcomes

  1. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Approximately 3 years

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: Approximately 3 years

    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  3. Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Time frame: Approximately 3 years

    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.

Secondary outcomes

  1. Part 1 and Part 2: Serum Concentrations of JNJ-63898081

    Time frame: Approximately 3 years

    Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.

  2. Part 1 and 2: Systemic Cytokine Concentrations

    Time frame: Approximately 3 years

    A panel of cytokines, including those proinflammatory ones, will be measured.

  3. Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies

    Time frame: Approximately 3 years

    Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.

  4. Serum Prostate Specific Antigen (PSA) Concentration

    Time frame: Approximately 3 years

    Serum prostate specific antigen (PSA) concentration will be assessed.

  5. Objective Response Rate (ORR)

    Time frame: Approximately 3 years

    ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).

  6. Duration of Response

    Time frame: Approximately 3 years

    Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2019
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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